Quality Management Services

We are firmly convinced that high-quality medical devices and professional quality management increase the quality of life in the long term.

In the highly regulated medical device market, a quality management system in accordance with EN ISO 13485, MDSAP or 21CFR820 (FDA) is generally mandatory to maintain product quality.

Our motivation is to develop a lean, adaptable and practical quality management system for our customers. The aim must be to ensure that the quality management system can be implemented in the long term without the need for additional support from Axxos. We want to see our customers grow!

Gap analysis and internal status audits
Qualification and Validation
Computer System Validation (CSV)
QMS for testing and calibration laboratories according to ISO 17025
FDA Services
Healthcare facilities
Swissmedic inspections
Update service standards and regulations